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A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
Obesity
Overweight
Knee Pain Chronic
Knee Osteoarthritis
Obstructive Sleep Apnea
The purpose of this study is to evaluate the efficacy and safety of retatrutide in
participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including
subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have
obstructive sleep apnea (OSA) (J1I-MC-GSA1). This... expand
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Type: Interventional Start Date: Jul 2023 |
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Infections
Infected Wound
Nonunion of Fracture
Injury Leg
Amputation
This is a Phase III clinical randomized control trial to investigate differences between
patient with an infected nonunion treated by PO vs. IV antibiotics. The study population
will be 250 patients, 18 years or older, being treated for infected nonunion after
internal fixation of a fracture with... expand
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured. Type: Interventional Start Date: May 2023 |
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in...
Multiple Myeloma
The main purpose of the study is to evaluate the safety and tolerability of the
combination of elranatamab and carfilzomib and dexamethasone or elranatamab and
maplirpacept.
There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of
elranatamab when given in combination... expand
The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose. Type: Interventional Start Date: Dec 2022 |
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Cutaneous Lupus Erythematosus (CLE)
The goal of this clinical study is to test how edecesertib (formerly known as GS-5718)
can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE.
Information on what is happening in the body relating to CLE, how the body processes, is
affected by and responds to the study... expand
The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study. Type: Interventional Start Date: Apr 2023 |
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival (...
Traumatic Injury
This is a prospective, multicenter, randomized, double-blind, placebo-controlled,
parallel-group, large simple trial to investigate the efficacy and safety of a single
intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed
or suspected acute major bleeding and /... expand
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion. Type: Interventional Start Date: Mar 2023 |
Evaluate REC-4881 in Patients With FAP
Familial Adenomatous Polyposis
This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis
(FAP). expand
This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis (FAP). Type: Interventional Start Date: Jul 2023 |
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study
Pulmonary Arterial Hypertension
Patients with pulmonary arterial hypertension (PAH) have reduced health related quality
of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most
patients die within ten years. Increasing physical activity is highly efficacious in PAH,
resulting in six-minute walk distance... expand
Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most patients die within ten years. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) and HRQOL improvement that often exceeds the effect of medications. Prior activity studies required inpatient rehabilitation, which is impractical, hard to sustain, and poorly scalable to a rare disease. The Investigators propose a randomized trial of smart texts versus usual care for 6 months. The Investigators will randomize 100 PAH patients to the mHealth intervention or usual care. The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire. The Investigators will also test the effect of an mHealth intervention on exercise capacity, measured by a supervised home-based 6MWD test. Finally, the Investigators will examine the effect of the intervention on time to clinical worsening (composite of PAH therapy escalation, PAH hospitalization, and death) one year after randomization. Type: Interventional Start Date: Jan 2023 |
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents,...
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Mixed Phenotype Acute Leukemia
Myelodysplastic Syndrome
This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using
mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD)
in treating children, adolescents, and young adults with acute leukemia or
myelodysplastic syndrome (MDS). HCT is considered... expand
This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical [haplo]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy and/or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all. Type: Interventional Start Date: Mar 2023 |
CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease
End Stage Renal Disease
Frailty and sarcopenia are modifiable risk factors for morbidity and mortality in
patients with ESRD. Exercise is the recommended intervention to prevent frailty and
sarcopenia, however, many clinical trials have shown limited clinical improvement in
muscle mass and physical function. We propose that... expand
Frailty and sarcopenia are modifiable risk factors for morbidity and mortality in patients with ESRD. Exercise is the recommended intervention to prevent frailty and sarcopenia, however, many clinical trials have shown limited clinical improvement in muscle mass and physical function. We propose that mitochondrial dysfunction is one of the deterrents to the effectiveness of the exercise. We plan to evaluate the additive effect of HIIT and CoQ10, a mitochondrial-targeted therapy, on mitochondrial function and physical performance. Understanding the interplay among CoQ10, exercise, and mitochondrial function will identify novel mechanisms to improve the efficiency of exercise. This will also serve to prevent frailty, sarcopenia, and muscle dysfunction in patients with ESRD. Type: Interventional Start Date: Jun 2023 |
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
Advanced Solid Tumors
The primary objective of this study is to identify the recommended phase 2 dose (RP2D)
and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of
ADCT-601 monotherapy and in combination with gemcitabine. expand
The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine. Type: Interventional Start Date: Jul 2022 |
Evaluating the Prevalence of Acute Hepatic Porphyria in Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome
Acute Hepatic Porphyria
Postural Tachycardia Syndrome (POTS) is the most common autonomic disorder and is
estimated to affect 3,000,000 individuals in the United States, with 80-85% of patients
being women. The condition is characterized by a rapid increase in heart rate (HR) that
occurs on standing, and chronic symptoms... expand
Postural Tachycardia Syndrome (POTS) is the most common autonomic disorder and is estimated to affect 3,000,000 individuals in the United States, with 80-85% of patients being women. The condition is characterized by a rapid increase in heart rate (HR) that occurs on standing, and chronic symptoms of cerebral hypoperfusion leading to lightheadedness, dizziness, and blurred vision. The acute hepatic porphyrias(AHP)are among the diseases that present with autonomic cardiovascular(tachycardia)and neurovisceral symptoms (abdominal pain) among others; they present with acute exacerbations Given that there is available treatment for AHP that change the natural progression of the disease, study focuses to investigate the occurrence of AHP in POTS and determine the clinical and neuro-hormonal characteristic of the POTS subgroup that will likely benefit from AHP screening. This study has one visit that involves, answering some questionnaires, coming to the lab for blood work, genetic testing, and some autonomic function tests. About 50 people will take part in this study. Type: Observational Start Date: Jan 2022 |
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the long-term safety
and tolerability of treatment with CC-93538. The study will enroll participants who
participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies. expand
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies. Type: Interventional Start Date: Sep 2021 |
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Delirium
Critical Illness
Sedation Complication
Executive Dysfunction
Post Traumatic Stress Disorder
Ventilated pediatric patients are frequently over-sedated and the majority suffer from
delirium, a form of acute brain dysfunction that is an independent predictor of increased
risk of dying, length of stay, and costs. Universally prescribed sedative medications-the
GABA-ergic benzodiazepines-worsen... expand
Ventilated pediatric patients are frequently over-sedated and the majority suffer from delirium, a form of acute brain dysfunction that is an independent predictor of increased risk of dying, length of stay, and costs. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction and independently prolong duration of ventilation and ICU stay, and the available alternative sedation regimen using dexmedetomidine, an alpha-2 agonist, has been shown to be superior to benzodiazepines in adults, and may mechanistically impact outcomes through positive effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium. The mini-MENDS trial will compare dexmedetomidine and midazolam, and determine the best sedative medication to reduce delirium and improve duration of ventilation, and functional, psychiatric, and cognitive recovery in our most vulnerable patients-survivors of pediatric critical illness. Type: Interventional Start Date: May 2021 |
Cholinergic Mechanisms of Attention in Aging
Subjective Cognitive Decline
This study will use an anticholinergic pharmacological probe to examine attention network
function in SCD using EEG. The overall hypothesis is that in older adults with SCD,
normal cognitive performance is maintained by compensatory attention network activity,
supported by enhanced cholinergic function.... expand
This study will use an anticholinergic pharmacological probe to examine attention network function in SCD using EEG. The overall hypothesis is that in older adults with SCD, normal cognitive performance is maintained by compensatory attention network activity, supported by enhanced cholinergic function. The investigators anticipate that SCD will be associated with greater compensatory attention network activity and that disrupting this compensatory process through anticholinergic challenge will result in a greater negative effect on attentional performance (Attention Network Test, ANT) and attention network functioning (EEG) in older adults with SCD compared to those without SCD. Type: Interventional Start Date: Apr 2022 |
Fenofibrate for Prevention of DR Worsening
Diabetic Retinopathy
This randomized trial will evaluate the effect of fenofibrate compared with placebo for
prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes
with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition to evaluating efficacy,... expand
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort. Type: Interventional Start Date: Mar 2021 |
Academic-Community EPINET (AC-EPINET)
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Major Depression with Psychotic Features
Bipolar Disorder with Psychotic Features
The investigators propose to examine the effects of CSC services delivered via TH
(CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes
in a 12-month, randomized trial. expand
The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial. Type: Interventional Start Date: Mar 2022 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal...
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVA Gastric Cancer AJCC v8
Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
This phase III trial studies how well the addition of radiotherapy to the usual treatment
(chemotherapy) works compared to the usual treatment alone in treating patients with
esophageal and gastric cancer that has spread to a limited number of other places in the
body (oligometastatic disease). Radiotherapy... expand
This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer. Type: Interventional Start Date: May 2020 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation
(chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating
patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin,
fluorouracil, and capecitabine, work in different... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Jan 2020 |
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed...
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
Central Nervous System Leukemia
Mixed Phenotype Acute Leukemia
Testicular Leukemia
This phase III trial studies whether inotuzumab ozogamicin added to post-induction
chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL)
improves outcomes. This trial also studies the outcomes of patients with mixed phenotype
acute leukemia (MPAL), and B-lymphoblastic... expand
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-consolidation treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of delayed intensification. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy. Type: Interventional Start Date: Oct 2019 |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic...
Castration Levels of Testosterone
Metastatic Prostatic Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
This phase III trial studies how well standard systemic therapy with or without
definitive treatment (prostate removal surgery or radiation therapy) works in treating
participants with prostate cancer that has spread to other places in the body. Addition
of prostate removal surgery or radiation therapy... expand
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Type: Interventional Start Date: Sep 2018 |
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Eosinophilic Gastrointestinal Disorders (EGIDs)
Eosinophilic Esophagitis
Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Colitis
The purpose of this observational study is to find the best measures to define how well a
person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally
undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis.
Treatments are then decided based... expand
The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing. Type: Observational Start Date: Jul 2015 |
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With...
Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome
This study will enroll male and female subjects who are 18 years of age or older with
Eosinophilic Granulomatosis With Polyangiitis. expand
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis. Type: Interventional Start Date: Dec 2023 |
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic...
Digestive System Neuroendocrine Tumor G1
Digestive System Neuroendocrine Tumor G2
Metastatic Digestive System Neuroendocrine Neoplasm
Metastatic Malignant Neoplasm in the Liver
Pancreatic Neuroendocrine Tumor G1
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor
radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible
(debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor
(SSTR) positive, gastroenteropancreatic... expand
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs Type: Interventional Start Date: May 2024 |
Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG...
Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
The purpose of the study is to prospectively assess longitudinal changes in biomarkers
(MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal
fluid (CSF) and blood; characterize longitudinal changes in performance on clinical
scales (clinician-reported measures of... expand
The purpose of the study is to prospectively assess longitudinal changes in biomarkers (MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal fluid (CSF) and blood; characterize longitudinal changes in performance on clinical scales (clinician-reported measures of neurodevelopment and functioning) and caregiver-reported outcome assessments (communication, gastrointestinal, social-emotional-adaptive behavioral measures); evaluate longitudinal changes in caregiver-reported health-related quality-of-life measures; and assess the frequency, type, and severity of seizures over time. Type: Observational Start Date: Oct 2023 |
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